The following data is part of a premarket notification filed by Authorized Hearing Systems, Inc. with the FDA for Rionet Hearing Aid Hb53-k.
| Device ID | K961907 |
| 510k Number | K961907 |
| Device Name: | RIONET HEARING AID HB53-K |
| Classification | Hearing Aid, Air Conduction |
| Applicant | AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST. Bristol, PA 19007 |
| Contact | Henry Smith |
| Correspondent | Henry Smith AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST. Bristol, PA 19007 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-16 |
| Decision Date | 1996-07-03 |